BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT CAPTIVIA THORACIC STENT GRAFT SYSTEM

    MDR report key: 3013581 · Received March 20, 2013

    Report

    Report Number
    2953200-2013-00501
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION METHOD, RESULTS AND CONCLUSIONS: (FILM). RESULTS: (ENDOLEAK). (TYPE II ENDOLEAK). CONCLUSION: (LACK OF MODELING AT THE TIME OF IMPLANT).

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.7 CM THORACIC AORTIC ANEURYSM APPROXIMATELY FIVE MONTHS AGO. THERE WAS MODERATE TORTUOSITY IN THE THORACIC AORTA AND MILD TORTUOSITY IN THE ILIAC ARTERIES. THE THORACIC AORTA 4 CM BELOW THE SUBCLAVIAN ARTERY WAS 37 MM IN DIAMETER. THE STENT GRAFTS WERE IMPLANTED 4 CM DISTAL TO THE SUBCLAVIAN ARTERY. THERE WAS MILD CALCIFICATION THROUGHOUT THE VESSELS. IT WAS REPORTED THAT THE PHYSICIAN REVIEWED A RECENT CT AND STATED THAT THERE WAS A PROXIMAL TYPE I ENDOLEAK. THE ANEURYSM AND VESSEL MORPHOLOGY HAVE NOT CHANGED. THE PHYSICIAN ELECTED TO TREAT THE PATIENT. AN ANGIOGRAM WAS PERFORMED AND REVEALED THAT THERE WAS A TYPE II ENDOLEAK COMING FROM INTERCOSTAL ARTERY BUT THERE WAS NO APPARENT PROXIMAL TYPE I ENDOLEAK; HOWEVER, THE PHYSICIAN ELECTED TO IMPLANT A VALIANT 4040100 PROXIMAL TO THE VALIANT 4040150 AS A PRECAUTIONARY MEASURE IN THE EVENT THERE WAS A TYPE I ENDOLEAK THAT THE ANGIOGRAM DID NOT REVEAL. THE POSSIBLE CAUSE OF THE TYPE I ENDOLEAK MAY HAVE BEEN DUE TO THE LACK OF MODELING OF THE STENT GRAFT AT THE TIME OF IMPLANT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. REVIEW OF RETURNED FILMS AT THE TIME OF IMPLANT, SHOW TWO VALIANT STENT GRAFTS WERE IMPLANTED. THERE APPEARED TO BE GOOD OVERLAPPING OF COMPONENTS AND NO STENT GRAFT ISSUES WERE OBSERVED. POST-IMPLANT CTA'S SHOW A POSSIBLE TYPE II ENDOLEAK NEAR THE MID-LENGTH OF THE PROXIMAL STENT GRAFT. IMAGES POST PROXIMAL CUFF IMPLANT WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115809 VALIANT CAPTIVIA THORACIC STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01028518

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Required Intervention